Dossier management
Sofus is ready to assist your company with all kinds of projects within applications and renewals, literature reviews and format updates. We can help you to check and prepare the application dossier for the different regulatory procedures within the EU and the Nordic area.
Sofus has a renowned software for preparing and managing dossiers in the eCTD-format. Sofus' eCTD-manager is compatible with all available eCTD-formats (xml).
Contact:
Linda Thunell
tel: +46 8 5600 2002, linda.thunell(at)sofus.se
Some of the services we provide within service area
Dossier Management are:
- Checking and preparing the application dossier for all EU submission procedures.
- Perform Due Diligence of a product’s regulatory status.
- Preparation and compilation of electronic dossiers for submission according to the regulatory requirements (eCTD and NEES)
- Management of the submission life-cycle during the application procedures and during the post-marketing phase.
- Bookmarking and hyperlinking of PDF documents
- Formatting of Word documents (e.g. final formatting of Module 2 and 3 documents)